Pulmicort Flexhaler

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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect
the rates observed in practice.

PULMICORT FLEXHALER (budesonide inhalation powder)

Patients 6 years and older

The incidence of common adverse reactions in Table 1 is based upon pooled data
reported in patients treated with PULMICORT FLEXHALER (budesonide inhalation powder) 180 or 90 mcg in two double blind, placebo-controlled clinical trials in which 226 patients (106 females
and 120 males) with mild to moderate asthma, previously receiving bronchodilators,
inhaled corticosteroids, or both, were treated with PULMICORT FLEXHALER (budesonide inhalation powder) , administered
as 360 mcg twice daily for 12 weeks. In these trials, the patients on PULMICORT
FLEXHALER had a mean age of 28 years (range 6-80 years) and were predominantly
Caucasian (59.7%) and Asian (31.4%). Table 1 includes all adverse reactions
(regardless of investigator causality assessment) that occurred at a rate of
≥ 1% in the PULMICORT FLEXHALER (budesonide inhalation powder) group and more commonly than the placebo group.

Table 1 : Adverse Reactions occurring at an incidence of
≥ 1% and more commonly than placebo in the PULMICORT FLEXHALER (budesonide inhalation powder) group: pooled
data from two 12-week, double-blind, placebo-controlled clinical asthma trials
in patients 6 years and older

Long-Term Safety in Patients 6 years of age and older

Non-placebo controlled long-term studies in children (at doses up to 360 mcg
daily), and adolescent and adult subjects (at doses up to 720 mcg daily), treated
for up to one year with PULMICORT FLEXHALER (budesonide inhalation powder) , revealed a similar pattern and
incidence of adverse events.

PULMICORT TURBUHALER; a different PULMICORT DPI

The following adverse reactions occurred in placebo-controlled clinical trials
with similar or lower doses with inhaled budesonide via a different PULMICORT
dry powder inhaler with an incidence of ≥ 1% in the budesonide group and were
more common than in the placebo group:

In a 20-week trial in adult asthmatics who previously required oral corticosteroids,
the incidence of adverse reactions was evaluated with 400 mcg twice daily (N=53)
and 800 mcg twice daily (N=53) of inhaled budesonide via a different PULMICORT
dry powder inhaler and compared with placebo (N=53). In considering these data,
the increased average duration of exposure for inhaled budesonide patients (78
days for inhaled budesonide vs. 41 days for placebo) should be taken into account.
Adverse reactions, regardless of investigator causality assessment, reported
in more than five patients in the budesonide group and which occurred more commonly
than the placebo group in decreasing order of frequency include: respiratory
infection, sinusitis, headache, oral candidiasis, pain, asthenia, dyspepsia,
arthralgia, cough increased, nausea and rhinitis.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use
of PULMICORT FLEXHALER (budesonide inhalation powder) . Because these reactions are reported voluntarily from
a population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.